About Company:
Evolution Research Group (ERG) is dedicated to delivering high-quality Phase I–IV clinical trial execution to help sponsors bring lifesaving and life-enhancing therapies to market quickly and safely. Founded in 2014, ERG has grown into a leading neuroscience clinical development company, with affiliate sites across the U.S.and deep expertise in clinical pharmacology, psychiatry, neurology, acute pain, and metabolic disorders. ERG has completed over 5,000 trials and continues to expand into high-need therapeutic areas in the U.S. and globally.
Why join us? We offer a supportive culture, meaningful work, and the opportunity to contribute to cutting-edge research alongside industry leaders. Plus, we offer competitive benefits include medical and dental coverage, a matching 401(k), and paid time off to recharge.
Job Description:
ERG is the largest independent clinical research site services company focused on special populations and is the market leader in CNS. With 18 wholly owned clinical sites, we conduct in-patient and out-patient phase I-IV clinical research studies. Our mission is to provide the highest quality execution of clinical trials in all clinical research phases aimed at helping sponsor companies to get their life saving or life enhancing drugs to market as quickly and safely as possible.
The Assistant Coordinator participates in clinical research studies conducted by the Clinical Research Coordinator. They assist and perform a variety of duties involved in the collection, compilation, documentation and analysis of clinical research data.
Responsibilities:
Administrative:
- Monitor and ensure study data is collected following plan of care, guidelines and identified group resources
- Serve in rotation with assistant clinical coordinators and clinical research coordinators
- Serve as liaison between assigned clinical research coordinator and all clinical departments
- Participate in collaborative team efforts with other departments
- Discuss and administer Informed Consent Form
- Check and ensure that procedure areas are properly stocked with study supplies and equipment (i.e. blood tubes, kits, study flowsheets, ECG machines, BP cuffs, etc.)
- Assist assigned Clinical Research Coordinator review study schedules to ensure that study procedures are properly staffed
- Assist assigned Clinical Research Coordinator with the creation and/or review of study flowsheets to ensure study is conducted according to protocol requirements
- Anticipate, recognize, and resolve issues
- Reads and understands each protocol in which she/he is involve
- Follow established guidelines in the collection of clinical data and/or administration of clinical studies
- Performs all other duties as assigned
Clinical Responsibilities
- Support adverse event reporting and informed consent administration
- Notify staff of abnormal results or incidents
- Ensure participant comfort and readiness for procedures
- Set up supplies and procedure areas per protocol
- Perform venipuncture, vital signs, ECG, and other assessments
- Communicate with participants to explain procedures and gather data
- Assist with patient care and emergency measures as needed
- Attend study initiation meetings and perform study-related tasks
- Provide high-quality care under pressure
Educational:
- Maintains current licensure, registration and/or certification within educational background
- Maintains current BLS and/or ACLS certification
- Maintains necessary CEU’s for licensure, registration and/or certification
- Actively participates on CPMI’s ongoing Quality Assurance Program, HIPAA and Compliance Programs
- Keeps apprised of all new OSHA and GCP/ICH rules and regulations
- Attends all appropriate team meetings regarding study protocols
- Maintains skills in use of EKG machines, Holter hook-up and monitoring, diabetic monitoring and taking accurate vital signs
- Reads and understands CPMI policy and procedures manuals, SOP manual and employee handbook
Skills Required
- Current licensure, registration, and/or certification appropriate to the candidate’s educational background
- Current BLS and/or ACLS certification
- Current continuing education units required for licensure, registration, or certification
- Knowledge of HIPAA and compliance requirements
- Knowledge of OSHA and GCP/ICH rules and regulations
- Skills using EKG machines and performing Holter hookups and monitoring
- Ability to perform diabetic monitoring and obtain accurate vital signs
- Ability to perform venipuncture and clinical assessments
- Ability to provide high-quality participant care under pressure
What We Do
ERG is a leading U.S. based, privately held, independent clinical research site company, and provider of clinical development services with an expertise in early and late stage neuroscience drug development. With 21 wholly owned clinical sites and 5 affiliated sites, we conduct in-patient and out-patient phase I-IV clinical research studies. ERG has 340+ in-patient beds, a large and growing database of patients suffering from mental illness, neurological disorders, sleep disorders, addictions, Acute and Chronic Pain, diabetes and other illnesses as well as normal healthy volunteers who participate in trials for the advancement of medicine. With access to over 32 million patients/subjects and 5000 + completed trials, ERG continues to grow its capabilities and expand into indications where there are tremendous unmet medical needs in the United States and globally. The ERG portfolio of sites we own consists of Woodland International Research Group, Woodland Research Northwest, Midwest Clinical Research, Pacific Research Network, Clinical Pharmacology of Miami, Brain Matters Research, Neuropsychiatric Research Center, Richmond Behavioral Associates, Finger Lakes Clinical Research, Endeavor Clinical Trials, and HD Research, all supported by an industry leading centralized infrastructure located in New Jersey. ERG offers consulting services to pharmaceutical and CRO clients, including access to key opinion leaders in Schizophrenia, Pain, Alzheimer’s disease, Sleep Disorders, Depression, Hepatic/Renal Impairment, Podiatry and Clinical Pharmacology. This includes Rater Training Services, Centralized Data Services (ECG, PSG, EEG, qEEG, Actigraphy), Medical Writing Services, Study Feasibility and Site Recommendation ERG also offers general consulting in study design, protocol review and budget planning, vendor resources, Scientific Advisory Board Planning and Implementation, study feasibility and site recommendations.
